Citing a need for improvement in the way Philips has handled its duty to notify patients of the recall of a variety of its ventilators and breathing aids, the FDA issued an order to the corporation earlier this month mandating a more open flow of information.
In a statement on the agency’s website, the director of its Center for Devices and Radiological Health acknowledged ...
continue reading...
A Florida man has filed a class-action lawsuit against Abbott Laboratories after his daughter grew ill after consuming a recalled batch of formula. The infant developed “diarrhea, abdominal pain, severe diaper rash with blisters and blood, dehydration, sleeplessness, and other pain and injuries” after being fed meals of Similac Alimentum formula. The plaintiff alleges that the girl, while recovered, is still experiencing gastrointestinal distress as result.
The ...
continue reading...
Shortly after the Class I recall of a number of Philips CPAP and other breathing assistance devices, a company that sells and markets a sanitization system for the devices has also been sued. Plaintiffs allege that the SoClean CPAP sanitization system uses an unsafe amount of ozone in its sanitization process. This process is alleged to contribute to and accelerate the degradation of the sound ...
Batches of Similac, Alimentum, and EleCare powdered baby formula were found to be contaminated with a variety of bacteria. The infected batches originated out of a Sturgis, Michigan manufacturing facility for Abbott Nutrition and may have caused at least one infant death. Reports of bacterial infections in infants that consumed the formula were received in Texas, Ohio, and Minnesota.
“Parents and caregivers of infants who have used ...
continue reading...
The Food and Drug Administration recently notified executives at medical device manufacturer Medtronic that its efforts at rectifying significant issues within its diabetes business are falling short. “In summary,” the agency said, “your corrective actions are still in process, and you have not yet conducted effectiveness checks to ensure the updated procedures and required employee training will prevent reoccurrence of the identified deficiencies.”
The letter comes ...
continue reading...More recalls have been ordered for a variety of ventilators made by Dutch electronics and technology manufacturer Philips. The company’s troubles started in fall of last year when lines of Philips CPAPs, BiPAPs, and ventilators were recalled over concerns that the sound dampening foam used in the devices could degrade. This degradation could allow particles of the foam to enter the breathing circuits of the machines and ...
